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RECRUITING
NCT06447753
NA

COMPARATIVE EVALUATION OF DIRECT PULP CAPPING AND COMPLETE PULPOTOMY IN MATURE PERMANENT MANDIBULAR MOLARS WITH CLINICAL SIGNS INDICATIVE OF MODERATE PULPITIS

Sponsor: Postgraduate Institute of Dental Sciences Rohtak

View on ClinicalTrials.gov

Summary

Title: Comparative evaluation of direct pulp capping and complete pulpotomy in mature permanent mandibular molars with clinical signs indicative of moderate pulpitis: Randomized Clinical Trial Rationale: According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which are correspond to irreversible pulpitis. Complete/partial pulpotomy are suggested to be the choice of treatment for such cases. It has been suggested that infection is often the cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Based on this premise, DPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of partial/complete pulpotomy in adults Research Question Does Direct Pulp Capping have comparable outcome with complete pulpotomy in mature permanent teeth with clinical signs indicative of moderate pulpitis?

Official title: COMPARATIVE EVALUATION OF DIRECT PULP CAPPING AND COMPLETE PULPOTOMY IN MATURE PERMANENT MANDIBULAR MOLARS WITH CLINICAL SIGNS INDICATIVE OF MODERATE PULPITIS: RANDOMIZED CLINICAL TRIAL

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2023-06-01

Completion Date

2024-11-30

Last Updated

2024-06-07

Healthy Volunteers

Yes

Interventions

PROCEDURE

Direct pulp capping

after caries excavation, the pulp will be inspected visually. If bleeding present, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 6 min if required. Cases in which bleeding will not stop within 6 minutes will be excluded from the study and further managed by RCT. The exposed pulp will be capped with MTA which will be freshly mixed according to manufacturer's instructions and placed in thickness of 2 to 3 mm over the pulp exposure site using an amalgam carrier following which the cavity floor will be dabbed with moist sterile cotton pellet to ensure the setting of MTA, followed by application of a layer of light-cure RMGIC over MTA and light-curing for 20s. Then tooth will be restored using composite resin following etch and rinse technique.

PROCEDURE

Complete Pulpotomy

exposed pulp tissue will be amputated using fresh sterile large round diamond bur in a high-speed hand-piece under water coolant 28to the level of canal orifices. The pulp wound will be irrigated with 3% NaOCl. For hemostasis, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 6 min if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved within 6 minutes. After hemostasis, ProRoot MTA will be placed in thickness of 2 to 3 mm over the pulp exposure site using an amalgam carrier. After placement, the cavity floor will be dabbed with moist sterile cotton pellet to ensure the setting of MTA, followed by application of a layer of light-cure RMGIC over MTA and light-curing for 20s. The tooth then will be restored using composite resin following etch and rinse technique.

Locations (1)

PGIDS

Rohtak, Haryana, India